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Hormone · Profile

Follicle-Stimulating Hormone

FSH · Gonal-F · Follistim · Menopur

Pituitary & Trophic HormonesApproved
MW
980.2g/mol
Formula
C42H65N11O12S2

Follicle-stimulating hormone (FSH) is a glycoprotein hormone produced by the anterior pituitary gland that plays a crucial role in mammalian reproduction. Researchers primarily study FSH for its effects on gonadal function, particularly in the regulation of ovarian follicle development and spermatogenesis. Key findings indicate that FSH not only influences reproductive processes but also has significant roles in extragonadal tissues, such as regulating insulin secretion in pancreatic islets and glutamine synthesis in granulosa cells, which are vital for ovulation. Current research highlights the hormone's broader implications, including its potential involvement in metabolic disorders and bone health, suggesting that FSH may be a target for therapeutic strategies in conditions like polycystic ovary syndrome and diabetes. Clinical evidence indicates that understanding FSH's multifaceted roles could lead to novel interventions in reproductive and metabolic health.

Overview

Übersicht

Follicle-stimulating hormone (FSH) is an endogenous glycoprotein hormone produced by the anterior pituitary gland. It belongs to the chemical class of pituitary and trophic hormones and is crucial for reproductive processes. FSH is also available in synthetic forms such as Gonal-F and Follistim, which are used in clinical settings. Researchers have observed that FSH plays a significant role in mammalian reproduction by binding to its receptor, FSHR, which is expressed in the gonads and various extragonadal tissues. The primary physiological roles of FSH include the regulation of reproductive processes such as follicular development in ovaries and spermatogenesis in testes. Recent research has expanded its known functions to include roles in metabolic processes, such as glucose-stimulated insulin secretion in pancreatic islets, and potential implications in conditions like polycystic ovary syndrome (PCOS) and postmenopausal diabetes. The mechanism of action of FSH involves binding to the FSH receptor (FSHR), a G protein-coupled receptor, which activates pathways such as the cAMP/protein kinase A (PKA) and calcium pathways. This activation leads to various cellular responses, including gene expression changes, proliferation, differentiation, or apoptosis, depending on the physiological context. Pharmacokinetic properties of FSH include a circulating half-life that is subject to variation depending on the specific form and route of administration. Synthetic forms of FSH are used clinically to treat infertility and are regulated by health authorities worldwide. Researchers have found that FSH is approved for use in assisted reproductive technologies, and its regulatory standing varies by country.

Chemical profile

Chemische Struktur

Chemical structure of Follicle-Stimulating Hormone
FormelC42H65N11O12S2
Molekulargewicht980.2g/mol
CAS-Nummer146479-72-3
PubChem CID62819
Mechanism

Wirkmechanismus

FSH acts on the follicle-stimulating hormone receptor (FSHR), a G protein-coupled receptor, to activate the cAMP/protein kinase A (PKA) and calcium pathways. This activation leads to a biological cascade that regulates gene expression and cellular processes such as proliferation and differentiation in gonadal tissues.

Mechanism

Signalweg

Follicle-stimulating hormone (FSH) primarily acts through the follicle-stimulating hormone receptor (FSHR), activating the Gαs signaling pathway, which promotes the cAMP/protein kinase A (PKA) pathway and calcium influx to stimulate processes such as glucose-stimulated insulin secretion (GSIS) and granulosa cell function. Additionally, FSH can activate Gαi at high concentrations, inhibiting the cAMP/PKA pathway, leading to complex regulatory effects on insulin secretion and ovarian function. While the mechanisms of FSH action in reproductive and extragonadal tissues are being elucidated, some aspects remain incompletely understood, particularly regarding its broader physiological impacts beyond reproduction.

Half-Life & Pharmacokinetics

ENEndogenous

Circulating half-life ~3-4 hours

POOral

Poor bioavailability due to first-pass

Half-life may vary based on the specific synthetic form and route of administration.

Storage

Temperature

Refrigerate at 2-8C

Light

Protect from light

Form

Aqueous solution: use within specified period after opening

Notes

Ensure proper storage conditions to maintain stability and efficacy.

Solubility

Löslichkeit

FSH is soluble in water, which is relevant for its formulation as an injectable solution.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only), not a controlled substance under BtMG.

🇺🇸US

FDA approved for use in fertility treatments; prescription required.

🇦🇺AU

TGA Schedule 4 (prescription only medicine).

🇬🇧UK

Prescription only medicine (POM) as regulated by the MHRA.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the precise mechanisms by which FSH influences metabolic processes in extragonadal tissues, particularly in relation to its role in glucose metabolism and insulin secretion. Further research is needed to clarify the contradictory findings surrounding high FSH levels and their impact on insulin secretion, as well as to explore the long-term effects of FSH on metabolic health in diverse populations, including postmenopausal women and individuals with conditions like PCOS. Additionally, the relationship between myostatin, FSH synthesis, and fertility warrants further investigation through larger randomized controlled trials to understand the implications of targeting myostatin for muscle mass enhancement on reproductive health.

134 Research Publications

4,559

Total Citations

43

Human/RCT

3.2

Avg. Influence

2025

Latest

Sort
Filter
#01

Impairing follicle-stimulating hormone (FSH) signaling in vivo: targeted disruption of the FSH receptor leads to aberrant gametogenesis and hormonal imbalance.

AnimalInfluence32.0
857
The study demonstrated that targeted disruption of the follicle-stimulating hormone receptor in mice leads to hormonal imbalance and aberrant gametogenesis, highlighting its essential role in reproductive health.
#02

Men homozygous for an inactivating mutation of the follicle-stimulating hormone (FSH) receptor gene present variable suppression of spermatogenesis and fertility.

Case ReportInfluence12.0
546
Researchers observed that men homozygous for an inactivating mutation of the follicle-stimulating hormone receptor gene exhibit variable spermatogenic failure but do not show complete infertility.
#03

Recombinant human follicle stimulating hormone (r-hFSH; Gonal-F) versus highly purified urinary FSH (Metrodin HP): results of a randomized comparative study in women undergoing assisted reproductive techniques.

HumanInfluence14.0
202
Researchers demonstrated that recombinant human follicle-stimulating hormone was more effective than highly purified urinary FSH in inducing multiple follicular development in women undergoing assisted reproductive techniques.
#04

Luteinizing hormone and follicle stimulating hormone synergy: A review of role in controlled ovarian hyper-stimulation.

ReviewInfluence5.0
140
The review highlighted the complementary role of luteinizing hormone alongside follicle-stimulating hormone in ovarian stimulation, emphasizing the need for further research on optimal dosing in various patient populations.
#05

Follicle-stimulating Hormone (FSH) Action on Spermatogenesis: A Focus on Physiological and Therapeutic Roles.

Santi Daniele, et al. · Journal of clinical medicine · 2020

ReviewInfluence1.0
140
Researchers reviewed that follicle-stimulating hormone administration may improve fertility in men with idiopathic infertility, although its efficacy varies and requires further investigation.

Key findings

  1. 01FSH is important for the process of sperm production (spermatogenesis).
  2. 02The effectiveness of FSH treatment in men with infertility is not well established.
  3. 03Further research is needed to understand FSH's role and develop new treatment options.
#06

Mapping the follicle-stimulating hormone-induced signaling networks.

UnknownInfluence3.0
120
The review proposed a mapping of follicle-stimulating hormone-induced signaling networks, highlighting the complexity of its biological actions beyond the canonical pathways.
#07

LbetaT2 gonadotroph cells secrete follicle stimulating hormone (FSH) in response to active A.

AnimalInfluence6.0
115
The study demonstrated that activin A significantly stimulates follicle-stimulating hormone secretion in LbetaT2 gonadotroph cells, validating their use as a model for studying gonadotroph physiology.
#08

Follicle-stimulating hormone increases bone mass in female mice.

AnimalInfluence1.0
100
Researchers observed that elevated follicle-stimulating hormone levels in transgenic female mice increased bone mass independently of luteinizing hormone and estradiol, indicating an anabolic effect on bone.
#09

Efficacy of Follicle-Stimulating Hormone (FSH) Alone, FSH + Luteinizing Hormone, Human Menopausal Gonadotropin or FSH + Human Chorionic Gonadotropin on Assisted Reproductive Technology Outcomes in the "Personalized" Medicine Era: A Meta-analysis.

HumanInfluence3.0
91
Researchers observed that follicle-stimulating hormone alone resulted in a higher number of oocytes retrieved compared to combinations with luteinizing hormone or human chorionic gonadotropin in controlled ovarian stimulation.
#10

Multiple facets of follicle-stimulating hormone receptor function.

ReviewInfluence8.0
88
The study demonstrated that follicle-stimulating hormone (FSH) receptor activation triggers multiple signaling pathways that are essential for reproductive functions.

Clinical Trials (85)

Preclinical
Phase I
Phase II
Phase III
Approved

85

Total Trials

19,772

Total Enrolled

GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)

NCT01100333COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

2,552

Started

2008

Primary outcome

Consistency of dose of Gonal-f recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator

Infertility

A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation

NCT02607293COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

1,064

Started

2015

Primary outcome

Number of subjects with polycystic ovary

Polycystic Ovary Syndrome

Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment

NCT07128394RECRUITING
Sponsor

Nanjing University

Enrollment

590

Started

2024

Primary outcome

Proportion of cycles with no usable embryos

Infertility, FemaleLuteinizing Hormone (LH)

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

NCT00703014COMPLETED
Sponsor

Organon and Co

Enrollment

541

Started

2006

Primary outcome

Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)

PregnancyNeonates

A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α

NCT01111084COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

410

Started

2004

Primary outcome

Follicular development

Ovulation Induction

Purpose to Evaluate the Effectiveness of the Superovulation Stimulation Protocol Using Human Chorionic Gonadotropin (hCG) by Demonstrating Its Equivalence to Standard Controlled Ovarian Stimulation Protocols in Terms of Oocytes Retrieved, Blastulation While Maintaining an Economic Advantage

NCT07771283ENROLLING_BY_INVITATION
Sponsor

LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro

Enrollment

360

Started

2026

Primary outcome

Number of oocytes retrieved (oocyte yield)

Infertility (IVF Patients)Infertility Assisted Reproductive TechnologyInfertile PatientsInfertility DrugsInfertile Women Undergoing IVF or ICSIInfertilityStimulation in the OvaryInfertile Women Undergoing ARTControlled Ovarian SimulationInfertile Women Undergoing Assisted Reproductive Technology (ART)

Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

NCT00702273COMPLETED
Sponsor

Organon and Co

Enrollment

344

Started

2006

Primary outcome

Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

In Vitro Fertilization

Efficacy of Pergoveris in Aged IVF Patients

NCT02244866COMPLETED
Sponsor

Vietnam National University

Enrollment

240

Started

2012

Primary outcome

Clinical pregnancy

Infertility

Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation

NCT06572930RECRUITING
Sponsor

ART Fertility Clinics LLC

Enrollment

150

Started

2024

Primary outcome

Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.

Ovarian Stimulation

Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH

NCT00417157COMPLETED
Sponsor

Eugonia

Enrollment

135

Started

2007

Primary outcome

Live birth per started cycle

InfertilityPremature Ovarian Failure

Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

NCT00702546COMPLETED
Sponsor

Organon and Co

Enrollment

102

Started

2006

Primary outcome

Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

In Vitro Fertilization

In Vitro Maturation of Human Eggs

Sponsor

National Foundation for Fertility Research

Enrollment

100

Started

2015

Primary outcome

Pregnancy

InfertilityReproductive Techniques, Assisted

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

NCT02478775COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

99

Started

2015

Primary outcome

Difference Between Peak Inhibin B

ObesityFertility

Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

NCT01678651TERMINATED
Sponsor

IVI Madrid

Enrollment

80

Started

2012

Primary outcome

time of cell cleavage

Embryo Kinetics

Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles

NCT01286051COMPLETED
Sponsor

Houston Fertility Institute

Enrollment

80

Started

2011

Primary outcome

Pregnancy rates

Compare Pregnancy Rates Between FSH Stimulation and FSH andGnRH Antagonist

AMH and Dosing Regimens for Initial IVF Stimulation Protocols

NCT03098199COMPLETED
Sponsor

Reproductive Specialists of New York

Enrollment

78

Started

2015

Primary outcome

clinical pregnancy rate

Infertility

Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

NCT00702988COMPLETED
Sponsor

Organon and Co

Enrollment

44

Started

2003

Primary outcome

Pregnancy status at 20 weeks of gestation

PregnancyNeonates

Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation

NCT01669291COMPLETED
Sponsor

Main Line Fertility Center

Enrollment

43

Started

2012

Primary outcome

To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.

Fertility

Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors

NCT03354494COMPLETED
Sponsor

Fundacion Dexeus

Enrollment

40

Started

2016

Primary outcome

Total dose of gonadotrophins

Controlled Ovaria Stimulation

Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP

NCT01623570COMPLETED
Sponsor

Centro Riproduzione e Andrologia

Enrollment

40

Started

2011

Primary outcome

E2 in pmol/L

Hypogonadotropic Hypogonadism

Is in Vitro Maturation of Oocytes Influenced by the Origin of Gonadotropins Used in Maturation Medium: is There a Difference in Efficiency When Using Urinary Versus Recombinant Produced Follicle Stimulating Hormone and Human Chorionic Gonadotropin

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

35

Started

2022

Primary outcome

oocyte maturation

In Vitro Maturation of Oocytes

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)

NCT00702195COMPLETED
Sponsor

Organon and Co

Enrollment

29

Started

2002

Primary outcome

Pregnancy status at 20 weeks of gestation; Take-home baby rate

Pregnancy

An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen

NCT01080729TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

25

Started

2009

Primary outcome

Comparison between the initial Gonal-f FbM dose prescribed by the doctor and the initial Gonal-f FbM dose recommended by the CONSORT calculator

Multifollicular Stimulation

Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)

NCT01223079COMPLETED
Sponsor

Reproductive Medicine Associates of New Jersey

Enrollment

20

Started

2005

Primary outcome

Safety and efficacy of r-hFSH protocol

Outcome During r-hFSH StimulationOutcome During r-hFSH and r-hLH Stimulation

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)

NCT00702338COMPLETED
Sponsor

Organon and Co

Enrollment

1

Started

2008

Primary outcome

Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined

PregnancyNeonates

FSH Followed by HMG vs FSH Plus HMG in IVF

NCT04385342Phase 4UNKNOWN
Sponsor

Mansoura University

Enrollment

530

Started

2020

Primary outcome

Ongoing pregnancy rate

IVF

Nordic Luveris Study

NCT00553293Phase 4COMPLETED
Sponsor

Copenhagen University Hospital, Rigshospitalet

Enrollment

526

Started

2003

Primary outcome

Ongoing pregnancy rate per started stimulation cycle

InfertilityIn Vitro Fertilization

Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study

NCT01783301Phase 4COMPLETED
Sponsor

Vietnam National University

Enrollment

348

Started

2011

Primary outcome

Number of oocytes retrieved

Infertility

Tailored Ovarian Stimulation Based on BMI, AMH, AFC

NCT02430740Phase 4UNKNOWN
Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

300

Started

2016

Primary outcome

number of mature follicles

Infertility

Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

NCT06571214Phase 4NOT_YET_RECRUITING
Sponsor

Nanjing University

Enrollment

300

Started

2024

Primary outcome

Good quality embryo rate (cleavage stage)

Infertility

Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.

NCT01345812Phase 4TERMINATED
Sponsor

University of Aarhus

Enrollment

291

Started

2011

Primary outcome

Number of Top Quality Embryos day 2

Patients for In Vitro Fertilization(IVF)Treatment

Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).

NCT06921395Phase 4ACTIVE_NOT_RECRUITING
Sponsor

LG Chem

Enrollment

248

Started

2025

Primary outcome

Number of oocytes retrieved

Female Infertility

Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination

NCT00374634Phase 4COMPLETED
Sponsor

Nina la Cour Freiesleben

Enrollment

234

Started

2006

Primary outcome

Number of mature follicles in the study and control group.

Infertility

Assessment of Implantation Potential of Embryos by Time-lapse Technology

NCT01760278Phase 4UNKNOWN
Sponsor

Bloom IVF and Fertility Centre

Enrollment

200

Started

2012

Primary outcome

No.of top quality embryos produced in both the arms, study arm and control arm.

Embryo/Fetus DeathBlastocyst DisintegrationAneuploidyComplication of ImplantChemical Pregnancy

Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)

NCT00249834Phase 4COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

166

Started

2004

Primary outcome

Number of Oocytes Retrieved

Infertility

Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles

NCT04008966Phase 4COMPLETED
Sponsor

Cairo University

Enrollment

160

Started

2016

Primary outcome

number of mature follicular count

Assisted Reproduction

The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

NCT00334425Phase 4UNKNOWN
Sponsor

Central Jutland Regional Hospital

Enrollment

150

Started

2006

Primary outcome

Circulatory levels of Estradiol on the day of hCG

Infertility

Optimal Stimulation of Hypo-responders Undergoing in Vitro Fertilization (IVF)

NCT07121751Phase 4NOT_YET_RECRUITING
Sponsor

Dunamenti REK Istenhegyi IVF Center

Enrollment

150

Started

2025

Primary outcome

live clinical pregnancy

Hypo-responderInfertility (IVF Patients)OVARIAN STIMULATION

Biosimilar Versus Urinary Gonadotropins

NCT02503605Phase 4UNKNOWN
Sponsor

IVI Madrid

Enrollment

130

Started

2015

Primary outcome

Number of metaphase II oocytes

Infertility

NATural Ovarian Stimulation

NCT02892942Phase 4COMPLETED
Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

129

Started

2017

Primary outcome

Live birth obtained after IVF-ET

Infertility

Menopur Mixed Protocol

NCT01417195Phase 4COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

122

Started

2011

Primary outcome

Fertilization Rate

Infertility

Double Stimulation Followed by a Fresh Embryo Transfer

NCT04446845Phase 4COMPLETED
Sponsor

Fundación Santiago Dexeus Font

Enrollment

120

Started

2020

Primary outcome

Number of good-quality blastocysts

Infertility

Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG

NCT03208972Phase 4COMPLETED
Sponsor

AZ Jan Palfijn Gent

Enrollment

107

Started

2014

Primary outcome

The financial costs of the stimulation in both groups

Infertility

Role of FSHR Polymorphism p.N680S in the Therapy With FSH in Patients Who Underwent Varicocele Surgery

NCT02719093Phase 4UNKNOWN
Sponsor

U.O. Chirurgia Andrologica

Enrollment

100

Started

2016

Primary outcome

Total sperm count

Infertility, MaleVaricocele

Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

NCT02310074Phase 4UNKNOWN
Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

76

Started

2010

Primary outcome

pregnancy in the female partner

Idiopathic Hypogonadotropic Hypogonadism

Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility

NCT01250821Phase 4COMPLETED
Sponsor

Copenhagen University Hospital, Rigshospitalet

Enrollment

75

Started

2010

Primary outcome

The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation.

AnovulationInfertility

Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation

NCT00844311Phase 4COMPLETED
Sponsor

Rigshospitalet, Denmark

Enrollment

60

Started

2009

Primary outcome

Total number of top-quality embryos at day 3

Infertility

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

NCT04727671Phase 4COMPLETED
Sponsor

Damascus University

Enrollment

50

Started

2019

Primary outcome

Follicular fluid Placental Growth Factor (PlGF) Concentrations:

In Vitro FertilizationIntracytoplasmic Sperm InjectionInfertilityPolycystic Ovary Syndrome

Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

NCT04727684Phase 4COMPLETED
Sponsor

Damascus University

Enrollment

50

Started

2020

Primary outcome

Prevalence of oocyte dysmorphisms among the studied groups:

In Vitro FertilizationInfertilityIntracytoplasmic Sperm InjectionPolycystic Ovary Syndrome

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation

NCT02069808Phase 4COMPLETED
Sponsor

Michigan Reproductive Medicine

Enrollment

38

Started

2014

Primary outcome

number of mature oocytes recovered and cryopreserved.

Egg Donation

EXpression PRofile Endometrium Samples Study

NCT01210144Phase 4TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

27

Started

2008

Primary outcome

Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®

In Vitro Fertilization

Low-dose Gonal-f® in Ovulation Induction

NCT01871532Phase 4TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

24

Started

2013

Primary outcome

Percentage of Cycles With Monofollicular Development

InfertilityMonofollicular Development

Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])

NCT00328926Phase 4TERMINATED
Sponsor

EMD Serono

Enrollment

11

Started

2006

Primary outcome

Time to Clinical Pregnancy

Hypogonadotropic Hypogonadism

Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1

NCT01956110Phase 3COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

1,329

Started

2013

Primary outcome

Ongoing Pregnancy Rate

Infertility

Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF

NCT01687712Phase 3COMPLETED
Sponsor

Fertility Biotech AG

Enrollment

1,100

Started

2013

Primary outcome

Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population

Infertility

MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer

NCT00884221Phase 3COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

749

Started

2009

Primary outcome

Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set

Infertility

Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation

NCT02335879Phase 3COMPLETED
Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

534

Started

2008

Primary outcome

The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.

Anovulation

Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2

NCT01956123Phase 3COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

513

Started

2014

Primary outcome

Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles

Infertility

150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial

NCT07346235Phase 3NOT_YET_RECRUITING
Sponsor

American Hospital 2 Kosovo

Enrollment

440

Started

2026

Primary outcome

Cumulative Live Birth Rate per Initiated Cycle

Infertility, Female

Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

NCT05149924Phase 3COMPLETED
Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

354

Started

2018

Primary outcome

Number of oocytes retrieved

Infertility

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women

NCT04773353Phase 3COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

220

Started

2021

Primary outcome

Ongoing pregnancy rate

Infertility

PERgoveriS In Stratified Treatment for Assisted Reproductive Technique

NCT01297465Phase 3COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

202

Started

2011

Primary outcome

Total Number of Oocytes Retrieved

Assisted Reproductive TechniquesReproductive Technology, Assisted

Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF

NCT00378001Phase 3COMPLETED
Sponsor

IBSA Institut Biochimique SA

Enrollment

152

Started

2005

Primary outcome

The primary endpoint is the total number of oocytes retrieved.

Infertility

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

NCT01816321Phase 3COMPLETED
Sponsor

Universitair Ziekenhuis Brussel

Enrollment

150

Started

2013

Primary outcome

Ongoing pregnancy

InfertilityPoor Ovarian Response

Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)

NCT01185704Phase 3COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

136

Started

2008

Primary outcome

Estradiol (E2) Levels on r-hCG Day

Polycystic Ovarian Syndrome

Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle

NCT01071200Phase 3TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

133

Started

2005

Primary outcome

Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes

Reproductive Techniques, Assisted

Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

NCT03088137Phase 3COMPLETED
Sponsor

IVFarma LLC

Enrollment

118

Started

2017

Primary outcome

Oocytes (Intention-to-Treat, ITT)

Infertility, Female

Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

NCT02739516Phase 3COMPLETED
Sponsor

Benha University

Enrollment

108

Started

2014

Primary outcome

Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)

Unexplained Infertility

Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles

NCT02310919Phase 3COMPLETED
Sponsor

University of California, San Francisco

Enrollment

105

Started

2014

Primary outcome

Total Fertilization Proportion (i.e. Total Competent Proportion)

Infertility

A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®

NCT01820728Phase 3COMPLETED
Sponsor

Dong-A ST Co., Ltd.

Enrollment

93

Started

2007

Primary outcome

The ovulation rate after 3 cycles of the injection

InfertilityAnovulation

To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection

NCT06561594Phase 3NOT_YET_RECRUITING
Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

60

Started

2024

Primary outcome

Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks

Idiopathic Hypogonadotropic Hypogonadism

Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

NCT01785095Phase 3COMPLETED
Sponsor

IBSA Institut Biochimique SA

Enrollment

41

Started

2013

Primary outcome

Number of Patients Producing Anti-FSH Antibodies.

Oocyte Donation

Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)

NCT01337531Phase 2UNKNOWN
Sponsor

Genesis Center for Fertility & Human Pre-Implantation Genetics

Enrollment

200

Started

2011

Primary outcome

Ovarian Response

Polycystic Ovary Syndrome

A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve

NCT01110707Phase 2COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

131

Started

2005

Primary outcome

Mean Number of Metaphase II (M-II) Oocytes Retrieved

InfertilityOvulation Induction

A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age

NCT01075815Phase 2TERMINATED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

76

Started

2008

Primary outcome

Implantation Rate

InfertilityOvulation Induction

A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women

NCT01735422Phase 2COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

67

Started

1999

Primary outcome

Ovulation rate

Infertility

Lutropin Alfa in Women at Risk of Poor Response

NCT01112358Phase 2COMPLETED
Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

58

Started

2005

Primary outcome

Number of Oocytes Retrieved

Ovarian Stimulation

Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism

NCT00064987Phase 2TERMINATED
Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Enrollment

19

Started

2001

Primary outcome

LH

HypogonadismKallmann Syndrome

A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)

NCT00697255Phase 2TERMINATED
Sponsor

Organon and Co

Enrollment

8

Started

2007

Primary outcome

Percentage of Participants With Monofollicular Response (Monofollicular Rate)

Ovulation Induction

Replacement of Fresh Embryo Transfers (ETs) by Frozen Embryo Transfers (FETs) Using Vitrification

NCT00823121Phase 1/2UNKNOWN
Sponsor

Yazd Research & Clinical Center for Infertility

Enrollment

500

Started

2008

Primary outcome

implantation rate

In Vitro Fertilization

Pergoveris FD and Liquid China BE Study

NCT04899193Phase 1COMPLETED
Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Enrollment

72

Started

2021

Primary outcome

Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-t, adj) of Follitropin Alfa

Healthy

Multiple Dose FSH-GEX(TM) in Healthy Volunteers

NCT01477073Phase 1COMPLETED
Sponsor

Glycotope GmbH

Enrollment

57

Started

2011

Primary outcome

safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection

Female Infertility

Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

NCT02592031Phase 1COMPLETED
Sponsor

Merckle GmbH

Enrollment

49

Started

2009

Primary outcome

Comparison of single dose pharmacokinetics (Cmax)

Bioequivalence

Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application

NCT02459418Phase 1COMPLETED
Sponsor

Fertility Biotech AG

Enrollment

42

Started

2015

Primary outcome

Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]

Healthy Volunteers

Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women

NCT03535103Phase 1UNKNOWN
Sponsor

Alphamab Jilin Co., Ltd.

Enrollment

32

Started

2018

Primary outcome

Maxmum observed serum concentration (Cmax) of LM001&Gonal-f® in healthy Chinese female subjects.

Infertility, Female

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